ABSTRACT
The objective of this study is to assess the dose-related effects of tramadol on a group of patients with premature ejaculation [PE]. During the period of months between June 2010 and July 2012, 180 PE patients presented to outpatient clinic of our hospital. Patients were randomized in a 1:1:1 fashion to receive different sequences of the three medications: placebo, 50 mg of tramadol and 100 mg of tramadol. Every patient received 10 doses of each medication for 2 months. Intra-vaginal ejaculatory latency time [IELT] was recorded in seconds initially and for each arm. Successful treatment of PE is defined if IELT exceeded 120 s. Side-effects of medications were reported. Of patients enrolled, 125 [69.4%] continued the study. Patients' age range was 20-55 years with PE complaint of 1 to 10 years duration. Mean IELT was 72 at presentation, 82 for placebo, 150 for tramadol 50 mg, and 272 for tramadol 100 mg [P < 0.001 for all comparisons]. PE was successfully treated in only 2.4% of patients with placebo, in contrast to 53.6% and 85.6% with 50 and 100 mg tramadol, respectively [P < 0.001 for all comparisons]. On multivariate logistic regression analysis, baseline IELT was the only predictor of successful treatment of PE with both tramadol 50 mg [odds ratio [OR]: 1.05, 95% confidence interval [CI]: 1.03-1.07, P < 0.001] and tramadol 100 mg [OR: 1.07, 95% CI: 1.04-1.11, P < 0.001]. Postmicturition dribble annoyed 12.8% of those who received 50 mg tramadol and 33.6% of those who received 100 mg tramadol [P < 0.001]. Weak scanty ejaculation was the main complaint in 7.2% versus 21.6% of those using 50 and 100 mg tramadol, respectively [P = 0.002]. Two patients discontinued tramadol 100 mg due to side-effects. Tramadol hydrochloride exhibits a significant dose-related efficacy and side-effects over placebo for treatment of PE